Apparatus for performing plasmapheresis in situ



Aug. 12, 1969 v. G. LUCAS 3,460,752

APPARATUS FOR PERFORMING PLASMAPHERESIS IN SITU Original Filed Nov. 9,1965 2 Sheets-Sheet 1 INVENTOR- VICT SJ R GRIFOLS LUCAS QM, 74/664 Y/gZwn/ 2, 1969 v. G. LUCAS 3,460,752

APPARATUS FOR PERFORMING PLASMAPHERESIS IN SITU Original Filed Nov. 9,1965 2 Sheets-Sheet 2 l/\'\"li1\"TUR. V'ICTQR GRIFOLS LUCAS jaw-m1, 407WUnited States Patent "ice 3,460,752 APPARATUS FOR PERFORMINGPLASMAPHERESIS IN SITU Victor Grifols Lucas, Barcelona, Spain, assiguor,by mesne assignments, to American Hospital Supply Corporation, Evanston,Ill., a corporation of Illinois Original application Nov. 9, 1965, Ser.No. 502,190, now Patent No. 3,407,812, dated Oct. 29, 1968. Divided andthis application Sept. 12, 1968, Ser. No. 759,377

Int. Cl. B04b 9/12, 9/14; B01d 43/00 US. Cl. 233-26 7 Claims ABSTRACT OFTHE DISCLOSURE This application is a division of my co-pendingapplication Ser. No. 502,190, filed Nov. 9, 1965, now Patent No.3,407,812.

This invention relates to plasmapheresis, and more specifically, to anapparatus for performing plasmapheresis in situ.

In the past, whenever it has been desired to obtain human plasma byplasmapheresis, blood has first been withdrawn from the donor and hasthen been transmitted to a laboratory where it has been centrifuged toobtain separation of plasma from the red cells. Such a procedure hasbeen characterized by the following disadvantages:

(l) The donor must suffer venipuncture twice; first for withdrawal ofblood, and second, for re-injection of the red cells separated from hisown blood, the re-injection of such cells serving to speed the processof recuperation so that more frequent donations may be feasible.

(2) Centrifugation of blood in the laboratory requires a detailedcontrol in order to avoid mistakes that may produce shock in the donorif red cells from another person are administered to him.

(3) Repeated handling of the blood and its passage from one container toanother, as well as recuperation of the red cells for re-injection,amount to a series of operations which require considerable time andincrease the danger of infections and mistakes.

Accordingly, it is an object of the present invention to provide anapparatus for performing plasmapheresis in situ, thereby overcoming manyof the important disadvantageas and dangers in plasmapheresis as it isnow practiced. Specifically, it is an object to provide an apparatus forpracticing plasmapheresis in situ, thereby achieving importantadvantages in safety, asepsis and speed, to insure success with theleast possible inconvenience and danger to the honor.

Another object is to provide an apparatus in which withdrawal of blood,and the centrifugation of such blood, are both carried out in the samecontainer. In this connection, it is a specific object to provide anapparatus in which centrifugation is achieved by rotating the collectionbottle on its own axis. A further object is to provide an apparatus inwhich a blood collection bottle is not only utilized directly in thecentrifugation process,

3,460,752 Patented Aug. 12, 1969 but is supported in such a way thatre-injection of the red blood cells is greatly faciliated.

A still further object is to provide an apparatus in which a bloodcollection bottle is elastically suspended to avoid oscillations andvibrations, and thereby provide an automatic fixation of the spinningaxis, during a centrifugation process.

Other objects and advantages will be apparent from the specification anddrawings, in which:

FIGURE 1 is a perspective view of the complete apparatus embodying thepresent invention, such apparatus including an electric motorelastically suspending, and a carriage stand mounted for rotation by themotor and adapted to contain a collection bottle in inverted position;

FIGURE 2 is a longitudinal sectional view of the carriage stand;

FIGURE 3 is an exploded perspective view illustrating structural detailsof the stand;

FIGURE 4 is a broken perspective view of the lower portion of the bottleretainer showing the lower retaining ring;

FIGURE 5 is a perspective view of a disk adapted to be mounted in theretainers lower retaining ring;

FIGURE 6 is a view in reduced scale illustrating a first step inpracticing the method of the present invention;

FIGURE 7 is another view in reduced scale illustrating subsequent stepsin practicing such method.

Referring specifically to the drawings, I will now de scribe in detailthe construction and functional characteristics of the apparatus, andthe steps of the method, which permit practicing human plasmapheresis inthe same place where blood is collected and which also allows immediatere-injection to the donor of his own red cells.

The apparatus shown in FIGURE 1 comprises an electric motor 1 disposedvertically with its shaft 2 projecting downwardly. At the lower end ofthe motor housing is a horizontal plate or clamping member 3 which isprovided along its underside with a resilient pad or cushion 3a. Asecond clamping member 4, provided along its upper surface with asimilar pad or cushion 4a, is spaced beneath member 3 and is detachablyconnected thereto by vertical bolts 5 or by any other suitableconnecting means. By rotating wing nuts 5a, the distance between plates3 and 4 may be reduced or increased to either clamp or release asupporting arm 6 having a Y-shaped end portion 6a disposed between theplates. The opposite end of the arm is firmly secured to a standard (notshown) or other appropriate stationary support means.

Motor shaft 2 extends downwardly through apertures in both clampingplates and is connected at its lower end to an adaptation neck 7 whichconstitutes a union between the shaft and the upper plate 8 of a bottleretainer or support 9. A pin 10 (FIGURE 2) extends through the lowermostend of the shaft and securely anchors the motor shaft and plate 8 forsimultaneous rotation.

A collection bottle B, into whichblood withdrawn from a donor iscollected and in which centrifugation is thereafter immediatelyperformed, is disposed in inverted position within the cage-likeretainer 9. As shown in the drawings, retainer 9 comprises the upperdisk 8, lower retaining ring 12 and disk 13, and parallel columns 14extending between the upper disk 8 and the lower ring-disk assembly12-13. The 'four columns are arranged in uniformly and circumferentiallyspaced relation. On the columns, another disk or plate 15 is slidablymounted and bears against the bottom of inverted bottle B. Disk 15 isurged downwardly by helicoidal expansion springs 16' concentricallymounted on the columns and interposed between upper plate 8 and disk 15.The extent of spring expansion is limited by lugs 17 connected to therespective columns. Lugs 17 therefore serve as stops to limit the extentof downward movement of disk under the influence of springs 16.

Lower ring 12 is provided on its upper surface with a plurality ofuniformly and circumferentially spaced notches or recesses 12a. Inaddition, the inner surface of the ring is provided with a like numberof recesses or openings 1217, such recesses being uniformly spaced fromeach other and preferably being disposed substantially equal distancescircumferentially between notches 12a. Disk 13 is adapted to fit withinthe large central opening of ring 12 and, as shown clearly in FIGURE 5,has a plurality of uniformly and circumferentially spaced ears 18. Thecars project outwardly and are of semicircular shape, as are therecesses or openings 12b of ring 12, and the two parts (disk 13 and ring12) are so mated that the disk may be moved upwardly into the largecentral opening of the ring with its ears 18 slidably received withinopening or recesses 12b. Disk 13 is also provided with a central opening19 for receiving the neck of bottle B.

It is to be noted that the diameter of the large central opening of ring12 is greater than the diameter of bottle B. Therefore, the bottle maybe introduced into the cagelike retainer by inserting it upwardly ininverted position until its base engages the undersurface ofspring-loaded plate 15. Disk 13 is fitted onto the inverted neck of thebottle, and the plate and bottle are then urged upwardly to compresssprings 16 and to permit the ears 18 of the disk to pass upwardlythrough openings 12b. Thereafter, disk 13 is rotated until ears 18 seatwithin notches or recesses 12a. The weight of the bottle B, combinedwith the downward force exerted by springs 16, hold the cars 18 inposition within recesses 125; during the centrifugation step.

It will be observed that when the apparatus is assernbled as shown inFIGURE 1, stationary arm 6 supports the unit at a point or Zone betweenmotor 1 and bottle retainer 9. This arrangement, coupled with thecushioning effect of padded clamping members 3 and 4, substantiallyeliminates or dampens vibrations which might otherwise occur duringcentrifugation. As will be brought out later, it is important thatvibrations which might produce turbulence of blood duringcentrifugation, and during the gradual reduction in rotational speed ofthe retainer following a period of centrifugation, be avoided.

Preferably, the motor is constructed to rotate shaft 2 and retainer 9 ata speed of between 1500 to 3000 revolutions per minute. It is imperativethat the motor be constructed and arranged, or controlled in itsoperation, so that deceleration of the retainer 9 and theblood-containing bottle B, following a period of centrifugation, occurgradually over-an interval in excess of 3 minutes. Such gradualdeceleration is necessary to prevent turbulence in the blood and topermit a substantially complete separation of plasma and red cells. Thegradual and uniform deceleration may be easily achieved by constructingthe rotating parts to spin with minimum friction and also to possess, byvirtue of their mass, suificient momentum to spin for a period in excessof 3 minutes and preferably for a period in excess of 4 minutes, afterthe electric motor has been deenergized. In practice, a decelarationperiod in the range of 4 to 10 minutes, with an optiumum period ofapproximately 7 to 8 minutes, has been found particularly effective.Periods in excess of 10 minutes are not desirable because they undulyextend the plasmapheresis procedure without any appreciable increase inthe degree of red cell and plasma separation.

While gradual deceleration may be achieved as described above, it is tobe understood that similar results may be obtained with rotating partshaving greater friction and less mass by simply gradually reducing theelectric power supplied to the motor over an interval in excess of 3minutes and, preferably, in excess of 4 minutes.

To practice plasmapheresis in situ, using the apparatus just described,venipuncture is first performed with the needle 21 of a conventionalblood collection set 22, and then collecting the blood in a sterile,partially-evacuated bottle B (FIGURE 6). Bottle B is a standardbloodcollection bottle, having its neck 20 closed with a selfsealingrubber stopper 23. Blood flows through the collection set into thebottle and, after a predetermined amount of blood (normally 500 ccs.)has been collected, standard clamp 24 is manipulated to close thebloodcollection tube and the filling needle 25 is withdrawn from theself-sealing stopper 23 and, as indicated in broken lines in FIGURE 7,is inserted into the drip tube assembly 26 connected to a suspendedbottle 27 containing sterile physiological saline. The sterile saline isallowed to flow along the tube 22 which connects to the donors vein.This allows (1) some degree of replenishment of the total fluid lost bythe donor during the withdrawal of blood and (2) the maintenance ofpatency of the needle which was previously inserted into the donors veinand which has not been removed therefrom. Failure to maintain a slowflow of physiologically compatible liquid through this needle wouldresult in the formation of a clot within the needle.

Blood bottle B is entirely conventional and contains standard amounts ofan approved anti coagulant substance such as, for example, citrate,heparin, or EDTA.

After the filling needle 25 has been removed from the self-sealingstopper of the blood bottle, the substantially filled bottle is placedwithin retainer 9, in the position shown in FIGURES l and 2, and motor 1is energized to centrifuge the collected blood for a period of 15 to 20minutes, including deceleration time. Centrifugation causes the redcells to migrate outwardly against the inside wall surfaces of thebottle, thereby separating the cells from the plasma which remains inthe bottles axial zone. Following centrifugation, the bottle is allowedto remain undisturbed in the stationary retainer 9 for a further periodof l to 3 minutes, at which time the red cells which have been driven tothe wall of the bottle during centrifugation slide downwardly and occupythe lower portion of the inverted bottle.

As indicated by the solid lines in FIGURE 7, a typical airway needle 28is then inserted into self-sealing stopper 23 and into communicationwith the air tube (not shown) within the blood bottle. Thereafter, driptube assembly 26 is withdrawn from the stopper of the saline bottle 27and the needle of that assembly is inserted into the stopper of theinverted blood bottle. The contents of the bottle are allowed to flowthrough the tube system 22 into the donors vein until exactly half thecontents of the blood bottle (approximately 250 ccs.) have been soadministered. The administration procedure is then discontinued byclosing clamp 24, and needle 21 is withdrawn from the donors vein.

The residual contents of the blood bottle will consist of plasmacontaminated by a certain small proportion of red cells. In practice,this contamination amounts to between 2 to 5% of the 250 ccs. residualvolume. The contaminating red cells are subsequently removed from theplasma by the use of a conventional centrifuge. This degree of red cellloss is quite insignificant and is considered to be small enough topermit a healthy individual to be subjected to the plasmapheresisprocedure disclosed herein several times in a week.

It will be noted that throughout the plasmapheresis procedure, needle 21remains in position in the donors vein. Only a single venipunctureoccurs and, since the entire procedure is conducted at the donorsbedside, there is no danger that the red cells returned to the donor mayhave been taken from someone else. The entire procedure is performedsafely and relatively quickly, in 25 minutes or less, with no discomfortto the donor except possibly for that occasioned by the singlevenipuncture.

While in the foregoing I have disclosed the method and apparatus of theinvention in considerable detail for purposes of illustration, it willbe understood that many of these details may be varied without departingfrom the spirit and scope of the invention.

I claim:

1. An apparatus for performing plasmapheresis in situ, comprising aninverted cylindrical bottle disposed with its axis oriented vertically,said bottle having a downwardly tapered neck portion terminating in astoppered opening, a bottle retainer supporting said bottle forrotational movement about the vertical axis thereof, an electric motoroperatively connected to said retainer for rotating and supporting thesame, and supporting means for supporting said motor, said supportingmeans including cushioning means for resiliently supporting said motorand thereby absorbing vibrations which might otherwise be transmitted tosaid bottle during operation of said motor.

2. The structure of claim 1 in which said motor has an operating speedWithin the range of approximately 1500 to 3000 revolutions per minute,the frictional resistance to rotation and the mass of the rotatableparts being such that upon de-energization of said motor the fulldeceleration of said retainer and fiuid-containing bottle carriedthereby Will occur over an interval in excess of three minutes.

3. The structure of claim 1 in which said bottle is detachably supportedby said retainer.

4. In an apparatus for practicing plasmapheresis in situ, an electricmotor oriented with its shaft extending vertically, a bottle retainer ofgenerally cylindrical configuration having t he longitudinal axisthereof extending vertically and having one end thereof secured to saidmotor shaft for rotation of said retainer about said axis when saidmotor is operated, said bottle retainer defining a chamber forsupporting an inverted blood-containing bottle having a downwardlytapered neck portion terminating in an axially-oriented stopperedopening, and support means for supporting said motor, said support meansincluding cushioning means for resiliently supporting said motor andthereby absorbing vibrations which might otherwise be transmitted tosaid blood bottle during operation' of said motor.

5. The structure of claim 4 in which said motor shaft has a rotationalspeed within the range of approximately 1500 to 3000 revolutions perminute, the fractional resistance to rotation and the mass of therotatable parts being such that upon de-energization of said motor thefull deceleration of said retainer and a blood bottle carried therebywill occur gradually over an interval in References Cited German printedapplication, 1,128,180, Lennart, Apr. 19, 1962.

WILLIAM I. PRICE, Primary Examiner US. Cl. X.R. 233-1

